Nerivio Shows Effectiveness as Acute Migraine Treatment in Large-Scale, Real-World Analyses


Device-related adverse events were reported in less than 1% of the safety analysis population, which included more than 100,000 patients with migraine who were treated with Nerivio.

Jessica Ailani, MD, FAHS, FAAN

Jessica Ailani, MD, FAHS, FAAN

Newly published real-world analyses highlighted the use of Theranica’s Nerivio remote electrical neuromodulation (REN) device as an effective, safe, and sustainable intervention to treat acute migraine.1,2

The peer-reviewed study included several analyses of the device, including REN-medication combinations, efficacy across multiple treatments, and safety. With more than 100,000 total participants included in the peer-reviewed study, Alon Ironi, chief executive officer, and cofounder, Theranica, said in a statement, "to the best of our knowledge, this study is the largest prospective real-world evidence analysis of a migraine device to date."1

REN-medication combinations, the first analysis, included data on 22,329 treatments for which a medication report was available. Of these, 66.5% (n = 14,854) of the treatments were REN used as a standalone acute therapy, 12.9% (n = 2886) were REN used in combination with over-the-counter medications, 11.2% (n = 2497) were REN used in combination with triptans, and 9.4% (n = 2092) were REN used in combination with other prescription medicines.2

READ MORE: National Headache Foundation Announces Position Statement on Treatment of Migraine

The efficacy analysis, which included solely those who used REN as a standalone treatment (n = 2514 patients; 12,735 treatments), 50% response was recorded in 66.5% of users for pain relief, and in 22.6% for pain freedom. Furthermore, 61.3% of users achieved reduction in their functional disability in at least 50% of their treatments, and 29.8% of users achieved return to normal function in at least 50% of their treatments.

"The current analysis of a very large group of patients, over a long period of time and multiple treatments, reinforces that REN provides a safe, efficacious and stable treatment option for acute treatment of migraine, both as a standalone and as an adjunct therapy. This is a very important component in the migraine therapy toolbox." Jessica Ailani, MD, FAHS, FAAN, director, MedStar Georgetown Headache Center, and primary investigator of the study, said in a statement.1

Prescribed as a digital therapeutic, Nerivio became the first FDA-cleared smartphone-controlled wearable device for the acute treatment of migraine in October 2020. Worn on the upper arm at the onset of a migraine attack, the device utilizes REN to trigger an endogenous analgesic mechanism, known as conditioned pain modulation.

Additional data from the efficacy analysis showed that 32% of those with episodic migraine and 21% of those with chronic migraine achieved pain freedom 2 hours post-treatment in most of their treatments, and more than 65% experienced sustained pain relief at 2-hours.

More than 80% of those in the analyses were prescribed Nerivio by headache specialists (n = 2012), and the rest by primary care physicians (PCPs; n =365). When comparing the 2 prescriber affiliations, there were slightly greater percentages of patients prescribed by PCPs who demonstrated 50% treatment response in areas such as pain relief (77.8% vs 64.4%), pain freedom (32.2% vs 20.9%), improvement in function (67.5% vs 60.2%), and return to normal function (41.6% vs 27.7%).2

The safety analysis included data on 121,947 treatments, conducted by more than 12,368 users, during the analyzed time period, with 59 (0.48%) of them reporting device-related adverse events (AE). Of these 56 (0.45%) were mild, 3 (0.03%) were moderate, and none were severe. Investigators most observed local paresthesia in the area of the device AE and momentary painful increase in the stimulation intensity as frequent side effects. Notably, no severe AEs were reported.

"This kind of long time, large-population real-world data is exactly the type of evidence required by health insurance organizations to feel confident about a new therapy in the market,” Scott Serota, former chief executive officer, Blue Cross Blue Shield Association, and current member on Theranica’s Board of Directors, said in a statement.1

1. Large real-world evidence analysis provides comprehensive evaluation of Nerivio as an effective acute treatment for migraine. News release. Theranica BioElectronics. January 19, 2022. Accessed January 24, 2022.
2. Ailani J, Rabany L, Tamir S, Ironi Al, Starling A. Real-world analysis of remote electrical neuromodulation (REN) for the acute treatment of migraine. Front Pain Res. Published online January 18, 2022. doi:10.3389/fpain.2021.7537336
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